{
"NDC": [
{
"NDCCode": "42799-952-30",
"PackageDescription": "30 PACKET in 1 CARTON (42799-952-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (42799-952-01) ",
"NDC11Code": "42799-0952-30",
"ProductNDC": "42799-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "GRANULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216247",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230815",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium for delayed-release oral suspension is indicated for.",
"Description": "The active ingredient in pantoprazole sodium for delayed-release oral suspension, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white or almost white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium for delayed-release oral suspension is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength 40 mg pantoprazole, (equivalent to 45.1 mg of pantoprazole sodium), contains the following inactive ingredients: hypromellose, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, povidone K-30, sodium carbonate, sodium lauryl sulfate, talc, triethyl citrate, and yellow ferric oxide."
},
{
"NDCCode": "42799-054-02",
"PackageDescription": "30 TABLET in 1 BOTTLE (42799-054-02) ",
"NDC11Code": "42799-0054-02",
"ProductNDC": "42799-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminocaproic Acid",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212110",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210602",
"SamplePackage": "N",
"IndicationAndUsage": "Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruption placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach. and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).",
"Description": "Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Each Aminocaproic Acid Tablet USP, for oral administration contains 500 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "42799-605-03",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42799-605-03) ",
"NDC11Code": "42799-0605-03",
"ProductNDC": "42799-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215001",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200925",
"SamplePackage": "N",
"IndicationAndUsage": "Loperamide Hydrochloride Capsules (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide Hydrochloride Capsules is also indicated for reducing the volume of discharge from ileostomies.",
"Description": "Loperamide Hydrochloride Capsules USP (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl- a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Loperamide Hydrochloride Capsules USP is available in 2mg capsules. The inactive ingredients are: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, colloidal silicon dioxide. In addition, the hard gelatin capsule also contains gelatin, black iron oxide, red iron oxide, titanium dioxide and yellow iron oxide. The black printing ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide."
},
{
"NDCCode": "42799-920-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42799-920-30) ",
"NDC11Code": "42799-0920-30",
"ProductNDC": "42799-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212678",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "2.5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190430",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP, are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective(cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprololfumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate....................................................... 2.5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................…. 5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................... 10 mg. Hydrochlorothiazide….................................................... 6.25 mg. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, and titanium dioxide. The 5 mg/6.25 mg tablet also contains D&C red #30. The 2.5 mg/6.25 mg tablet also contains D&C yellow #10 aluminum lake and FD&C yellow #6."
},
{
"NDCCode": "42799-921-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42799-921-30) ",
"NDC11Code": "42799-0921-30",
"ProductNDC": "42799-921",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212678",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190430",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP, are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective(cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprololfumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate....................................................... 2.5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................…. 5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................... 10 mg. Hydrochlorothiazide….................................................... 6.25 mg. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, and titanium dioxide. The 5 mg/6.25 mg tablet also contains D&C red #30. The 2.5 mg/6.25 mg tablet also contains D&C yellow #10 aluminum lake and FD&C yellow #6."
},
{
"NDCCode": "42799-922-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42799-922-30) ",
"NDC11Code": "42799-0922-30",
"ProductNDC": "42799-922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212678",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190430",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets, USP, are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective(cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprololfumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate....................................................... 2.5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................…. 5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................... 10 mg. Hydrochlorothiazide….................................................... 6.25 mg. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, and titanium dioxide. The 5 mg/6.25 mg tablet also contains D&C red #30. The 2.5 mg/6.25 mg tablet also contains D&C yellow #10 aluminum lake and FD&C yellow #6."
},
{
"NDCCode": "42799-954-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01) ",
"NDC11Code": "42799-0954-01",
"ProductNDC": "42799-954",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203713",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients are carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coating contains red and yellow iron oxide, hydroxypropyl methylcellulose, polysorbate, titanium dioxide and triacetin. USP Dissolution Test pending."
},
{
"NDCCode": "42799-961-01",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-961-01) ",
"NDC11Code": "42799-0961-01",
"ProductNDC": "42799-961",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213927",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) (1.1) Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine Extended-Release Tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl) ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended-Release Tablets use matrix core and extended release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release; the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 75 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyvinyl alcohol graft polyethylene glycol copolymer, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1."
},
{
"NDCCode": "42799-962-01",
"PackageDescription": "30 TABLET in 1 BOTTLE (42799-962-01) ",
"NDC11Code": "42799-0962-01",
"ProductNDC": "42799-962",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride, Extended Release",
"NonProprietaryName": "Venlafaxine Hydrochloride, Extended Release",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230315",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209193",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230315",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1."
},
{
"NDCCode": "42799-963-01",
"PackageDescription": "30 TABLET in 1 BOTTLE (42799-963-01) ",
"NDC11Code": "42799-0963-01",
"ProductNDC": "42799-963",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride, Extended Release",
"NonProprietaryName": "Venlafaxine Hydrochloride, Extended Release",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230315",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209193",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230315",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1."
},
{
"NDCCode": "42799-970-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42799-970-30) ",
"NDC11Code": "42799-0970-30",
"ProductNDC": "42799-970",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofacitinib",
"NonProprietaryName": "Tofacitinib",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218668",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "11",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Tofacitinib is a Janus kinase (JAK) inhibitor:Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers., 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers., 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers., 4 Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.",
"Description": "Tofacitinib extended-release tablets is formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H 8O7. The chemical structure of tofacitinib citrate is. Tofacitinib extended-release tablets is supplied for oral administration as a 11 mg brownish red, oval, extended-release film-coated tablet debossed with \"11\" on one side. Each 11 mg tablet of tofacitinib extended-release contains 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, hypromellose 2208 K100LV, mannitol DC200, hydroxypropyl cellulose (Klucel EXF), magnesium stearate and pink film coating. Coloring film coat contains: hypromellose 2910, titanium dioxide, triacetin and iron oxide red."
},
{
"NDCCode": "10812-952-01",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (10812-952-01)",
"NDC11Code": "10812-0952-01",
"ProductNDC": "10812-952",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Skin Makeup",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf20 - Buff 30",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130611",
"EndMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "66",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "16590-952-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-952-30)",
"NDC11Code": "16590-0952-30",
"ProductNDC": "16590-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090467",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hypertension. Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Hypertensive Patients with Left Ventricular Hypertrophy. Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See and , PRECAUTIONS Race, CLINICAL PHARMACOLOGY, , .) Pharmacodynamics and Clinical EffectsReduction in the Risk of StrokeRace. in 2 Patients NephropathyTypeDiabetic. Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see , CLINICAL PHARMACOLOGY). Pharmacodynamics and Clinical Effects.",
"Description": "Losartan potassium is an angiotensin II receptor (type AT ) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ -( - -tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. 1po1H. Its empirical formula is C H ClKN O, and its structural formula is: 22226. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "21130-952-30",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (21130-952-30) ",
"NDC11Code": "21130-0952-30",
"ProductNDC": "21130-952",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clear Anti Itch",
"NonProprietaryName": "Pramoxine Hcl, Zinc Acetate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090428",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE; ZINC ACETATE",
"StrengthNumber": "10; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090428",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac. dries the oozing and weeping of poison: . ivy. oak. sumac."
},
{
"NDCCode": "23155-952-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (23155-952-03) ",
"NDC11Code": "23155-0952-03",
"ProductNDC": "23155-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzphetamine Hydrochloride",
"NonProprietaryName": "Benzphetamine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202061",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "BENZPHETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260619",
"SamplePackage": "N",
"IndicationAndUsage": "Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.",
"Description": "Benzphetamine hydrochloride tablets, USP contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, α-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each benzphetamine hydrochloride tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Crospovidone, Colloidal Silicon Dioxide, Calcium Stearate, Opadry 15B540001 Pink (which contains Titanium dioxide, Hypromellose, Polyethylene Glycol, Polysorbate 80, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake)."
},
{
"NDCCode": "33261-952-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-952-30)",
"NDC11Code": "33261-0952-30",
"ProductNDC": "33261-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071251",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "37.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.). .",
"Description": "Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula."
},
{
"NDCCode": "35356-952-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-952-30)",
"NDC11Code": "35356-0952-30",
"ProductNDC": "35356-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077899",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "37835-952-30",
"PackageDescription": "355 mL in 1 BOTTLE (37835-952-30) ",
"NDC11Code": "37835-0952-30",
"ProductNDC": "37835-952",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180111",
"EndMarketingDate": "20211001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Bi-Mart",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2021-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180111",
"EndMarketingDatePackage": "20211001",
"SamplePackage": "N"
},
{
"NDCCode": "43063-952-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-952-30) ",
"NDC11Code": "43063-0952-30",
"ProductNDC": "43063-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076900",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201018",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g. on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone."
},
{
"NDCCode": "43744-952-30",
"PackageDescription": "50 g in 1 DRUM (43744-952-30)",
"NDC11Code": "43744-0952-30",
"ProductNDC": "43744-952",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Trifluridine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100723",
"EndMarketingDate": "20130630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "TRIFLURIDINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130630"
},
{
"NDCCode": "49349-952-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (49349-952-02)",
"NDC11Code": "49349-0952-02",
"ProductNDC": "49349-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49999-952-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (49999-952-30)",
"NDC11Code": "49999-0952-30",
"ProductNDC": "49999-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Singulair",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20120321",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020830",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-23"
},
{
"NDCCode": "52125-952-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-952-02)",
"NDC11Code": "52125-0952-02",
"ProductNDC": "52125-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076161",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-20"
},
{
"NDCCode": "54575-952-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (54575-952-30)",
"NDC11Code": "54575-0952-30",
"ProductNDC": "54575-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "2-oak Mix, Red/white Pollen",
"NonProprietaryName": "Quercus Rubra Pollen And Quercus Alba Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN",
"StrengthNumber": ".5; .5",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "61919-952-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (61919-952-30) ",
"NDC11Code": "61919-0952-30",
"ProductNDC": "61919-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090467",
"LabelerName": "Direct_Rx",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190821",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hypertension. Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy. Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 1.3 Nephropathy in Type 2 Diabetic Patients. Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)].",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. [Figure 1]. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "62713-952-01",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62713-952-01) ",
"NDC11Code": "62713-0952-01",
"ProductNDC": "62713-952",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergena",
"ProprietaryNameSuffix": "Texas Trees Kids",
"NonProprietaryName": "Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Texas Tree, Texas Weed, Texas Grass",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA ALBA POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS NIGRA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; RUMEX CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII POLLEN; TAXODIUM DISTICHUM POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20121221",
"SamplePackage": "N",
"IndicationAndUsage": "Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies."
},
{
"NDCCode": "62713-952-03",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62713-952-03) ",
"NDC11Code": "62713-0952-03",
"ProductNDC": "62713-952",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergena",
"ProprietaryNameSuffix": "Texas Trees Kids",
"NonProprietaryName": "Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Texas Tree, Texas Weed, Texas Grass",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
"SubstanceName": "ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS CRASSIFOLIA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA ALBA POLLEN; LIGUSTRUM VULGARE POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; PROSOPIS JULIFLORA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA ANGUSTIFOLIA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA FRIGIDA POLLEN; RUMEX OBTUSIFOLIUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ANNUA POLLEN; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; ARRHENATHERUM ELATIUS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; AGROSTIS GIGANTEA POLLEN; PHALARIS ARUNDINACEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM X DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN",
"StrengthNumber": "3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20121221",
"SamplePackage": "N"
},
{
"NDCCode": "63187-952-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-30) ",
"NDC11Code": "63187-0952-30",
"ProductNDC": "63187-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079095",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion Hydrochloride Extended-release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1‑ dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13 H18 ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion Hydrochloride Extended-release Tablets USP (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, and magnesium stearate. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol."
},
{
"NDCCode": "63940-952-30",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (63940-952-30) ",
"NDC11Code": "63940-0952-30",
"ProductNDC": "63940-952",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clear Anti-itch",
"NonProprietaryName": "Pramoxine Hcl, Zinc Acetate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110317",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Liberty Procurement, Inc",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE; ZINC ACETATE",
"StrengthNumber": "10; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110317",
"SamplePackage": "N"
},
{
"NDCCode": "65862-952-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-952-30) ",
"NDC11Code": "65862-0952-30",
"ProductNDC": "65862-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207983",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below:Fingolimod hydrochloride USP is a white to practically white powder that is freely soluble in water and alcohol. It has a molecular weight of 343.93 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: maltodextrin, sodium stearyl fumarate, talc. The empty hard gelatin capsule shell contains gelatin, iron oxide black, iron oxide yellow and titanium dioxide. The capsules are imprinted with black edible ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42799-952-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (42799-952-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (42799-952-01) </PackageDescription>
<NDC11Code>42799-0952-30</NDC11Code>
<ProductNDC>42799-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>GRANULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216247</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium for delayed-release oral suspension is indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for delayed-release oral suspension, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white or almost white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium for delayed-release oral suspension is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength 40 mg pantoprazole, (equivalent to 45.1 mg of pantoprazole sodium), contains the following inactive ingredients: hypromellose, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, povidone K-30, sodium carbonate, sodium lauryl sulfate, talc, triethyl citrate, and yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>42799-054-02</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42799-054-02) </PackageDescription>
<NDC11Code>42799-0054-02</NDC11Code>
<ProductNDC>42799-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminocaproic Acid</ProprietaryName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212110</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruption placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach. and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).</IndicationAndUsage>
<Description>Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Each Aminocaproic Acid Tablet USP, for oral administration contains 500 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>42799-605-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42799-605-03) </PackageDescription>
<NDC11Code>42799-0605-03</NDC11Code>
<ProductNDC>42799-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215001</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loperamide Hydrochloride Capsules (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide Hydrochloride Capsules is also indicated for reducing the volume of discharge from ileostomies.</IndicationAndUsage>
<Description>Loperamide Hydrochloride Capsules USP (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl- a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Loperamide Hydrochloride Capsules USP is available in 2mg capsules. The inactive ingredients are: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, colloidal silicon dioxide. In addition, the hard gelatin capsule also contains gelatin, black iron oxide, red iron oxide, titanium dioxide and yellow iron oxide. The black printing ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>42799-920-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42799-920-30) </PackageDescription>
<NDC11Code>42799-0920-30</NDC11Code>
<ProductNDC>42799-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212678</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>2.5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets, USP, are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective(cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprololfumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate....................................................... 2.5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................…. 5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................... 10 mg. Hydrochlorothiazide….................................................... 6.25 mg. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, and titanium dioxide. The 5 mg/6.25 mg tablet also contains D&C red #30. The 2.5 mg/6.25 mg tablet also contains D&C yellow #10 aluminum lake and FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>42799-921-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42799-921-30) </PackageDescription>
<NDC11Code>42799-0921-30</NDC11Code>
<ProductNDC>42799-921</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212678</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets, USP, are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective(cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprololfumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate....................................................... 2.5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................…. 5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................... 10 mg. Hydrochlorothiazide….................................................... 6.25 mg. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, and titanium dioxide. The 5 mg/6.25 mg tablet also contains D&C red #30. The 2.5 mg/6.25 mg tablet also contains D&C yellow #10 aluminum lake and FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>42799-922-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42799-922-30) </PackageDescription>
<NDC11Code>42799-0922-30</NDC11Code>
<ProductNDC>42799-922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212678</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets, USP, are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective(cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprololfumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate....................................................... 2.5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................…. 5 mg. Hydrochlorothiazide….................................................... 6.25 mg. Each bisoprolol fumarate and hydrochlorothiazide tablet 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate...................................................... 10 mg. Hydrochlorothiazide….................................................... 6.25 mg. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, and titanium dioxide. The 5 mg/6.25 mg tablet also contains D&C red #30. The 2.5 mg/6.25 mg tablet also contains D&C yellow #10 aluminum lake and FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>42799-954-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01) </PackageDescription>
<NDC11Code>42799-0954-01</NDC11Code>
<ProductNDC>42799-954</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203713</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>23</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients are carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coating contains red and yellow iron oxide, hydroxypropyl methylcellulose, polysorbate, titanium dioxide and triacetin. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>42799-961-01</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-961-01) </PackageDescription>
<NDC11Code>42799-0961-01</NDC11Code>
<ProductNDC>42799-961</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213927</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) (1.1) Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine Extended-Release Tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl) ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended-Release Tablets use matrix core and extended release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release; the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 75 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyvinyl alcohol graft polyethylene glycol copolymer, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1.</Description>
</NDC>
<NDC>
<NDCCode>42799-962-01</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42799-962-01) </PackageDescription>
<NDC11Code>42799-0962-01</NDC11Code>
<ProductNDC>42799-962</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride, Extended Release</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride, Extended Release</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230315</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209193</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230315</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1.</Description>
</NDC>
<NDC>
<NDCCode>42799-963-01</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42799-963-01) </PackageDescription>
<NDC11Code>42799-0963-01</NDC11Code>
<ProductNDC>42799-963</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride, Extended Release</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride, Extended Release</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230315</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209193</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230315</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1.</Description>
</NDC>
<NDC>
<NDCCode>42799-970-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42799-970-30) </PackageDescription>
<NDC11Code>42799-0970-30</NDC11Code>
<ProductNDC>42799-970</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofacitinib</ProprietaryName>
<NonProprietaryName>Tofacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218668</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>11</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tofacitinib is a Janus kinase (JAK) inhibitor:Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers., 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers., 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers., 4 Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.</IndicationAndUsage>
<Description>Tofacitinib extended-release tablets is formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H 8O7. The chemical structure of tofacitinib citrate is. Tofacitinib extended-release tablets is supplied for oral administration as a 11 mg brownish red, oval, extended-release film-coated tablet debossed with "11" on one side. Each 11 mg tablet of tofacitinib extended-release contains 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, hypromellose 2208 K100LV, mannitol DC200, hydroxypropyl cellulose (Klucel EXF), magnesium stearate and pink film coating. Coloring film coat contains: hypromellose 2910, titanium dioxide, triacetin and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>10812-952-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (10812-952-01)</PackageDescription>
<NDC11Code>10812-0952-01</NDC11Code>
<ProductNDC>10812-952</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Skin Makeup</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf20 - Buff 30</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130611</StartMarketingDate>
<EndMarketingDate>20180201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>66</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16590-952-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-952-30)</PackageDescription>
<NDC11Code>16590-0952-30</NDC11Code>
<ProductNDC>16590-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090467</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hypertension. Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Hypertensive Patients with Left Ventricular Hypertrophy. Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See and , PRECAUTIONS Race, CLINICAL PHARMACOLOGY, , .) Pharmacodynamics and Clinical EffectsReduction in the Risk of StrokeRace. in 2 Patients NephropathyTypeDiabetic. Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see , CLINICAL PHARMACOLOGY). Pharmacodynamics and Clinical Effects.</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor (type AT ) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ -( - -tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. 1po1H. Its empirical formula is C H ClKN O, and its structural formula is: 22226. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>21130-952-30</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (21130-952-30) </PackageDescription>
<NDC11Code>21130-0952-30</NDC11Code>
<ProductNDC>21130-952</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clear Anti Itch</ProprietaryName>
<NonProprietaryName>Pramoxine Hcl, Zinc Acetate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE; ZINC ACETATE</SubstanceName>
<StrengthNumber>10; 1</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac. dries the oozing and weeping of poison: . ivy. oak. sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23155-952-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (23155-952-03) </PackageDescription>
<NDC11Code>23155-0952-03</NDC11Code>
<ProductNDC>23155-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzphetamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Benzphetamine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202061</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BENZPHETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below. Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Benzphetamine hydrochloride tablets, USP contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, α-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82. The structural formula (dextro form) is represented below. Each benzphetamine hydrochloride tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Crospovidone, Colloidal Silicon Dioxide, Calcium Stearate, Opadry 15B540001 Pink (which contains Titanium dioxide, Hypromellose, Polyethylene Glycol, Polysorbate 80, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>33261-952-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-952-30)</PackageDescription>
<NDC11Code>33261-0952-30</NDC11Code>
<ProductNDC>33261-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071251</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>37.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.). .</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula.</Description>
</NDC>
<NDC>
<NDCCode>35356-952-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-952-30)</PackageDescription>
<NDC11Code>35356-0952-30</NDC11Code>
<ProductNDC>35356-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077899</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37835-952-30</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (37835-952-30) </PackageDescription>
<NDC11Code>37835-0952-30</NDC11Code>
<ProductNDC>37835-952</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180111</StartMarketingDate>
<EndMarketingDate>20211001</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Bi-Mart</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180111</StartMarketingDatePackage>
<EndMarketingDatePackage>20211001</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-952-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-952-30) </PackageDescription>
<NDC11Code>43063-0952-30</NDC11Code>
<ProductNDC>43063-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076900</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g. on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone.</Description>
</NDC>
<NDC>
<NDCCode>43744-952-30</NDCCode>
<PackageDescription>50 g in 1 DRUM (43744-952-30)</PackageDescription>
<NDC11Code>43744-0952-30</NDC11Code>
<ProductNDC>43744-952</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Trifluridine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20100723</StartMarketingDate>
<EndMarketingDate>20130630</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>TRIFLURIDINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49349-952-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (49349-952-02)</PackageDescription>
<NDC11Code>49349-0952-02</NDC11Code>
<ProductNDC>49349-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49999-952-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (49999-952-30)</PackageDescription>
<NDC11Code>49999-0952-30</NDC11Code>
<ProductNDC>49999-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Singulair</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120321</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020830</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-952-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-952-02)</PackageDescription>
<NDC11Code>52125-0952-02</NDC11Code>
<ProductNDC>52125-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076161</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-20</LastUpdate>
</NDC>
<NDC>
<NDCCode>54575-952-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (54575-952-30)</PackageDescription>
<NDC11Code>54575-0952-30</NDC11Code>
<ProductNDC>54575-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>2-oak Mix, Red/white Pollen</ProprietaryName>
<NonProprietaryName>Quercus Rubra Pollen And Quercus Alba Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.5; .5</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>61919-952-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (61919-952-30) </PackageDescription>
<NDC11Code>61919-0952-30</NDC11Code>
<ProductNDC>61919-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090467</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension. Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy. Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 1.3 Nephropathy in Type 2 Diabetic Patients. Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. [Figure 1]. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62713-952-01) </PackageDescription>
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<ProprietaryName>Allergena</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Meditrend, Inc. DBA Progena Professional Formulations</LabelerName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.</IndicationAndUsage>
</NDC>
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<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62713-952-03) </PackageDescription>
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<ProductNDC>62713-952</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergena</ProprietaryName>
<ProprietaryNameSuffix>Texas Trees Kids</ProprietaryNameSuffix>
<NonProprietaryName>Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Texas Tree, Texas Weed, Texas Grass</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Meditrend, Inc. DBA Progena Professional Formulations</LabelerName>
<SubstanceName>ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS CRASSIFOLIA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA ALBA POLLEN; LIGUSTRUM VULGARE POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; PROSOPIS JULIFLORA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA ANGUSTIFOLIA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA FRIGIDA POLLEN; RUMEX OBTUSIFOLIUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ANNUA POLLEN; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; ARRHENATHERUM ELATIUS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; AGROSTIS GIGANTEA POLLEN; PHALARIS ARUNDINACEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM X DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2020-12-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-30) </PackageDescription>
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<ProductNDC>63187-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
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<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion Hydrochloride Extended-release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1‑ dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13 H18 ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion Hydrochloride Extended-release Tablets USP (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, and magnesium stearate. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>63940-952-30</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (63940-952-30) </PackageDescription>
<NDC11Code>63940-0952-30</NDC11Code>
<ProductNDC>63940-952</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clear Anti-itch</ProprietaryName>
<NonProprietaryName>Pramoxine Hcl, Zinc Acetate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110317</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Liberty Procurement, Inc</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE; ZINC ACETATE</SubstanceName>
<StrengthNumber>10; 1</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-952-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-952-30) </PackageDescription>
<NDC11Code>65862-0952-30</NDC11Code>
<ProductNDC>65862-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fingolimod</ProprietaryName>
<NonProprietaryName>Fingolimod</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207983</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below:Fingolimod hydrochloride USP is a white to practically white powder that is freely soluble in water and alcohol. It has a molecular weight of 343.93 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: maltodextrin, sodium stearyl fumarate, talc. The empty hard gelatin capsule shell contains gelatin, iron oxide black, iron oxide yellow and titanium dioxide. The capsules are imprinted with black edible ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
</NDCList>